GB/T 14233.3-2024

Upcoming

Test methods for infusion, transfusion, injection equipments for medical use—Part 3: Microbiological test methods

医用输液、输血、注射器具检验方法 第3部分:微生物学试验方法

Standard Type
GBT
ICS
11.040.20
CCS
C31
Status
Upcoming
Issue Date
2024-10-26
Implementation
2026-11-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies microbiological test methods for infusion, transfusion, and injection medical devices, including sterility tests, bacterial endotoxin tests, and antimicrobial effectiveness evaluations. It is applied in the quality control and regulatory testing of products such as intravenous (IV) sets, blood bags, and syringes within the healthcare manufacturing industry. The standard ensures these devices meet safety requirements for microbial contamination before clinical use.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.